Better safe than sorry

For all manufacturers the importance of providing quality products is paramount, but for the pharmaceutical industry it is essential, says Loma Systems

With rigorous quality standards to comply with, pharmaceutical manufacturers simply cannot afford to produce anything that is less than perfect. Consumers must be able to put their trust in the products they depend on and the consequences of a product scare can be catastrophic. Sophisticated end-of-line inspection equipment provides an essential safety net.

For the pharmaceutical industry the importance of providing quality products is paramount. Contaminated products or missing information leaflets can jeopardise the safety of the consumer and damage the reputation of the manufacturer beyond repair.

With millions of pounds being spent on r&d every year, manufacturers need to be confident that their products will meet the exacting standards of the industry. This drive to make a perfect product has resulted in online inspection equipment manufacturers developing products that have higher levels of performance to meet the demands of the industry.

endangering lives

Pharmaceutical brands will always be particularly vulnerable to negative publicity. The direct cost of a product recall, the ongoing negative impact on sales caused by damage to the brand and resulting litigation may in the end be quite significant in an industry where inaccuracy endangers lives. At the other end of the scale, packaged pharmaceutical products may have more minor imperfections such as missing or broken tablets, resulting in an incomplete course of medication or inaccurate dosage for consumers.

However many precautions pharmaceutical manufacturers take, or however strictly they comply with pharmaceutical safety procedures, it is impossible to state with absolute certainty that there is no possibility of contaminants infiltrating the production process. A foolproof quality inspection system is of paramount importance.

Today's sophisticated x-ray machines are capable not only of detecting metal and many other potentially hazardous contaminants but can also inspect for defective product, even counting for missing items. For this reason, x-ray systems are ideal for inspecting tablet containers and blister packs and for detecting broken or missing tablets or product information leaflets.

Alan Johnson, x-ray product manager at Loma Systems, explains: 'Unlike the more traditional methods of inspection, x-ray is increasingly being used as a multipurpose inspection device for finished packs where the analysis is down to tablet or inclusion level. X-ray systems offer benefits over other inspection methods because they are not affected by the chemical composition of the product or external effects in the production environment.'

In an x-ray detector system, product passes through a fan-shaped beam. As the x-rays penetrate the product they lose some of their energy, dependent on the density of the product at that point. An array of sensors arranged linearly under the conveyor detects the energy losses and sends signals back to a processor to create an image of the object being scanned. In addition to producing a visual image, sophisticated software is used to spot contamination or defective products. Alongside a general reduction in prices - due to better design and economies of scale in manufacture as x-ray detection becomes more widespread - it is the sophistication of the software that is bringing the greatest number of benefits and having the biggest impact on the growing demand for these systems.

Perhaps one of the greatest advantages of x-ray machines for the pharmaceutical industry is their ability to check for contaminants in items that are packed in metallised packaging, such as blisterpacks. This factor is growing in importance as brand image and consumer expectations are driving the trend for more products to be packaged in this way.

To achieve the high level of quality assurance required by the industry, pharmaceutical manufacturers are optimising quality procedures at all stages of production. Johnson continues: 'Metal detection continues to play a significant role in this process and is particularly suited to the inspection of freefall tablets, powders and granules where the risk of metal contamination is considered more prevalent.'

correct numbers

In addition to ensuring pharmaceutical products contain no foreign bodies or have no missing items, legislation states that it is essential that they meet the minimum weight requirements as stated on the packaging. The need for highly accurate checkweighing on the production line is therefore as important as either x-ray or metal detection systems. Checkweighing, for example, can ensure that a bottle of antibiotics or an oral contraceptive packet contains the correct number and weight of tablets as well as ensuring extra items such as instruction leaflets are included.

The more traditional methods of online inspection such as metal detection and checkweighing do, however, have their limitations and will in the future offer only incremental performance enhancements. Unlike the latest x-ray systems, metal detection is limited by the aperture size required and product effect.

For example, if the free-flow product has a level of oxide content which essentially creates a metallic effect, then this would be picked up by the metal detector sensor in addition to any metal contaminant. The speed of the product passing through the machine and vibration in the product environment will also create boundaries for checkweighing systems.

Looking to the future, Loma believes the development of x-ray technology will lead the way to ensuring 100% integrity of pharmaceuticals. Vision analysis and the detection of further product imperfections are key to the development of online inspection in the pharmaceutical sector. With quality control systems and procedures becoming ever more rigorous, manufacturers must conform to the levels of quality consumers have come to expect.